Disease details

臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238

22 trials found

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2016-000434-21-PT (EUCTR)	14/11/2016	14/09/2016	PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)	PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)	Relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Plegridy 125 micrograms INN or Proposed INN: Peginterferon beta-1a Other descriptive name: PEGINTERFERON BETA-1A Trade Name: Rebif 22 micrograms INN or Proposed INN: Interferon beta -1a Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 44 micrograms INN or Proposed INN: Interferon beta -1a Other descriptive name: INTERFERON BETA -1A Trade Name: Betaferon 250 microgram/ml INN or Proposed INN: Recombinant Interferon Beta-1b Other descriptive name: RECOMBINANT INTERFERON BETA-1B Trade Name: Extavia 250 micrograms/ml INN or Proposed INN: Recombinant Interferon Beta-1b Other descriptive name: RECOMBINANT INTERFERON BETA-1B Trade Name: Plegridy 63 micrograms INN or Proposed INN: Peginterferon beta-1a Other descriptive name: PEGINTERFERON BETA-1A	Biogen Portugal	NULL	Authorised-recruitment may be ongoing or finished	Female: yes Male: yes	75	Phase 4	Portugal
2	EUCTR2012-005086-12-PL (EUCTR)	07/01/2015	16/09/2014	Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin	Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial	relapsing multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA -1a Trade Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA -1b	Octapharma AG	NULL	Not Recruiting	Female: yes Male: yes	234	Phase 3	Serbia;Hungary;Poland;Ukraine;Austria;Russian Federation;Bulgaria;Germany
3	EUCTR2012-005086-12-BG (EUCTR)	14/11/2013	19/08/2013	Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin	Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial	relapsing multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA -1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA -1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA -1a	Octapharma AG	NULL	Not Recruiting	Female: yes Male: yes	234	Phase 3	Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
4	EUCTR2012-005086-12-DE (EUCTR)	12/11/2013	01/07/2013	Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin	Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial	relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA -1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA -1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA -1a	Octapharma AG	NULL	Not Recruiting	Female: yes Male: yes	216	Phase 3	Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
5	EUCTR2012-005086-12-HU (EUCTR)	31/07/2013	18/06/2013	Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin	Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial	relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA -1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA -1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA -1a	Octapharma AG	NULL	Not Recruiting	Female: yes Male: yes	216	Phase 3	Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
6	EUCTR2012-005086-12-AT (EUCTR)	05/07/2013	08/05/2013	Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin	Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial	relapsing multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA -1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA -1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA -1a	Octapharma AG	NULL	Not Recruiting	Female: yes Male: yes	216	Phase 3	Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
7	EUCTR2009-015556-15-NL (EUCTR)	13/08/2010	08/04/2010	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms solution for injection in pre-filled syringe Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting	Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
8	EUCTR2008-003706-33-GR (EUCTR)	10/03/2010	12/03/2009	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono International	NULL	Not Recruiting	Female: yes Male: yes	642	Phase 3	Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
9	EUCTR2008-003706-33-FR (EUCTR)	02/07/2009	12/03/2009	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono International	NULL	Not Recruiting	Female: yes Male: yes	642	Phase 3	Portugal;Estonia;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Norway;Sweden
10	EUCTR2008-003706-33-GB (EUCTR)	09/06/2009	27/11/2008	Clinical trial with oral cladribine in early Multiple Sclerosis (MS)	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2'-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono S.A. - Geneva	NULL	Not Recruiting	Female: yes Male: yes	600	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Sweden
11	EUCTR2008-003706-33-SE (EUCTR)	04/06/2009	09/04/2009	Clinical trial with oral cladribine in early Multiple Sclerosis (MS)	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono S.A. - Geneva	NULL	Not Recruiting	Female: yes Male: yes	600	Phase 3	United States;United Arab Emirates;Serbia;Portugal;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
12	EUCTR2008-003706-33-BG (EUCTR)	28/05/2009	09/07/2009	Clinical trial with oral cladribine in early Multiple Sclerosis (MS)	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono S.A. - Geneva	NULL	Not Recruiting	Female: yes Male: yes	600	Phase 3	Sweden;United States;United Arab Emirates;Portugal;Serbia;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway
13	EUCTR2008-003706-33-AT (EUCTR)	02/04/2009	24/11/2008	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono S.A. - Geneva	NULL	Not Recruiting	Female: yes Male: yes	600	Phase 3	Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
14	EUCTR2008-003706-33-DE (EUCTR)	31/03/2009	09/12/2008	Clinical trial with oral cladribine in early Multiple Sclerosis (MS)	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono S.A. - Geneva	NULL	Not Recruiting	Female: yes Male: yes	600	Phase 3	Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden;United States;United Arab Emirates;Portugal;Serbia;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain
15	EUCTR2008-003706-33-CZ (EUCTR)	24/03/2009	22/10/2008	Clinical trial with oral cladribine in early Multiple Sclerosis (MS)	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono S.A. - Geneva	NULL	Not Recruiting	Female: yes Male: yes	600	Phase 3	Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Estonia;Romania;Thailand;Spain;Bosnia and Herzegovina;Lebanon
16	EUCTR2008-003706-33-NO (EUCTR)	18/03/2009	09/12/2008	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono S.A. - Geneva	NULL	Not Recruiting	Female: yes Male: yes	600	Phase 3	Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
17	EUCTR2008-003706-33-BE (EUCTR)	16/03/2009	09/12/2008	Clinical trial with oral cladribine in early Multiple Sclerosis (MS)	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cladribine Product Code: L01BB04 INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono S.A. - Geneva	NULL	Not Recruiting	Female: yes Male: yes	600	Phase 3	Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Sweden
18	EUCTR2008-003706-33-PT (EUCTR)	06/03/2009	17/12/2008	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono SA - Geneva	NULL	Not Recruiting	Female: yes Male: yes	600	Phase 3	Portugal;Estonia;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Norway;Sweden
19	EUCTR2008-003706-33-ES (EUCTR)	29/01/2009	09/12/2008	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - ORAl CLadribine in Early MS (ORACLE MS) Trial	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS).Sujetos con un primer episodio de desmielinización clínica (Síndrome aislado desde el punto de vista clínico (CIS)) de alto riesgo de conversión a Esclerosis Múltiple (EM). MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2?-deoxy-ß-D-adenosine Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono International	NULL	Not Recruiting	Female: yes Male: yes	642	Phase 3	Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
20	EUCTR2008-003706-33-EE (EUCTR)	31/12/2008	20/11/2008	Clinical trial with oral cladribine in early Multiple Sclerosis (MS)	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono S.A. - Geneva	NULL	Not Recruiting	Female: yes Male: yes	600	Phase 3	Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Romania;Estonia;Thailand;Spain;Bosnia and Herzegovina;Lebanon
21	EUCTR2008-003706-33-FI (EUCTR)	18/12/2008	10/11/2008	Clinical trial with oral cladribine in early Multiple Sclerosis (MS)	A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial	Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS) MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cladribine INN or Proposed INN: CLADRIBINE Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA) Trade Name: Rebif 44 micrograms solution for injection Product Name: Interferon beta -1a FBS-free/HSA-free INN or Proposed INN: INTERFERON BETA -1A	Merck Serono S.A. - Geneva	NULL	Not Recruiting	Female: yes Male: yes	600	Phase 3	Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Estonia;Romania;Thailand;Spain;Bosnia and Herzegovina;Lebanon
22	EUCTR2004-004130-14-AT (EUCTR)	17/02/2005	13/01/2005	A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).	A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).	Male and female subjects with relapsing multiple sclerosis previously treated with interferon beta-1a (22 mcg or 44 mcg, SC three times a week).	Product Name: Natalizumab Product Code: Not Applicable INN or Proposed INN: natalizumab Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: Interferon beta -1a	Biogen Idec GmbH	NULL	Not Recruiting	Female: yes Male: yes	1050		Austria

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